Role Summary
Senior Calibration Technician responsible for performing, coordinating, and documenting calibration activities across manufacturing, laboratory, utility, and warehouse areas in a cGMP-regulated setting. Acts as a subject matter expert with oversight of vendors, contributes to investigations and SOP development, and supports onboarding and training of personnel.
Responsibilities
- Schedule, coordinate, and perform equipment, system, and instrument calibrations, or oversee vendor-performed calibrations. Reconcile calibration documentation per internal procedures and FDA guidelines. Support calibration-related deviations investigations and assist with CAPAs as required.
- Provide advanced support for calibration and verification on process-related, GMP-classified, or validated equipment. Collaborate with other teams to ensure SOP and cGMP compliance.
- Maintain, test, and troubleshoot calibrated instrumentation (pressure, temperature, flow, measurement devices). Initiate escalation and coordinate resolution with vendors or support teams as needed.
- Define specifications and manage vendor relationships for calibration service providers, OEMs, and suppliers; obtain quotes and documentation for procurement.
- Review vendor and temporary personnel work for technical accuracy and proper documentation; ensure adherence to calibration procedures.
- Complete and maintain accurate calibration records in accordance with GxP expectations using BM-RAM; support QA data review requests.
- Coordinate and support contract service providers, ensuring compliance with site procedures and GxP requirements.
- Maintain lifecycle documentation for calibrated instruments (installation records, calibration history, retirement status); manage inventory of standards and spare parts.
- Serve as site SME for calibration activities; support audits, investigations, SOP development, and cross-department guidance; oversee vendor performance.
- Assist with drafting/revision of SOPs; contribute to deviation/failure investigations; prepare calibration-related reports and audit responses as needed.
- Support onboarding and training of junior technicians; help develop familiarity with tools, systems, and practices to minimize downtime.
- Maintain training compliance by completing required trainings within due dates.
Qualifications
- Minimum Requirements:
- H.S. Diploma or GED
- 6+ years in a pharmaceutical, food, or chemical manufacturing environment as a calibration technician or equivalent
- Extensive instrumentation troubleshooting and repair of pneumatic, electronic, and hydraulic control systems
- Ability to perform electrical repairs per NEC
- Strong working knowledge of cGMP regulations
- Experience with building management systems
- Ability to handle confidential data
- Intermediate PC skills and experience with calibration/PM tracking software (e.g., Blue Mountain RAM)
- Preferred Qualifications:
- Associate Degree in engineering, life sciences, or related field or equivalent military training with six years instrumentation experience
- Working knowledge of Adept, CAD, Master Control, and TrackWise
Education
- Not specified beyond the minimum and preferred qualifications above
Additional Requirements
- On-site requirement: 100% on-site at Silver Spring, Maryland location